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Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Bascom Palmer Eye Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:
NCT01350024
First received: May 5, 2011
Last updated: May 6, 2011
Last verified: May 2011
History of Changes
  Purpose

Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. Both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques.

The investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. In addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.


Condition Intervention
Blepharoptosis
 Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bascom Palmer Eye Institute:

Primary Outcome Measures:
  • Pain control [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]
    Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.


Secondary Outcome Measures:
  • Efficacy of ptosis surgery [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Standard measures include marginal reflex distanced, palpebral fissure and levator fucntion will be used to assess the efficacy of the ptosis surgery and compared to the type of anesthesia the patient was given.

  • Pain Control [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]
    completion of survey to assess pain after surgery has been completed.


Estimated Enrollment: 50
Study Start Date: May 2011
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Frontal Nerve Block
Patients will receive a frontal nerve block for anesthesia
 Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
Frontal Nerve Block 5 cc will be administered preoperatively once.
Active Comparator: Subconjucntival Injection
Patients will receive a subconjunctival injection for anesthesia
 Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Patient with ptosis that requires correction
  • Patient is able to consent for themselves

Exclusion Criteria:

  • Patient unable to complete survey
  • Patient had prior lid surgery
  • Patient taking chronic pain medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350024

Contacts
Contact: Chad C Zatezalo, MD 305-326-6000 ext 6788 czatezalo@med.miami.edu
Contact: Wendy Lee, MD 305-325-6000 ext 6788 wlee@med.miami.edu

Locations
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Chad C Zatezalo, MD     305-326-6000 ext 6788     czatezalo@med.miami.edu    
Contact: Wendy Lee, MD     305-326-6000 ext 6788     wlee@med.miami.edu    
Principal Investigator: Wendy Lee, MD            
Sub-Investigator: Chad C Zatezalo, MD            
Sponsors and Collaborators
Bascom Palmer Eye Institute
  More Information

No publications provided

Responsible Party: Wendy Lee, MD, Bascom Palmer Eye Institute, University of Miami
ClinicalTrials.gov Identifier: NCT01350024     History of Changes
Other Study ID Numbers: 20100631
Study First Received: May 5, 2011
Last Updated: May 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Bascom Palmer Eye Institute:
Conjunctival Mullerectomy
Blepharoptosis
Ptosis surgery
Pain Control

Additional relevant MeSH terms:
Blepharoptosis
Pain, Postoperative
Eyelid Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Epinephrine
Epinephryl borate
Lidocaine
Anesthetics
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013